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New treatment option for Aplastic Anemia
Official title Phase I/II Study of Anti-CD38 Monoclonal Antibody in Refractory Severe Aplastic Anemia
ClinicalTrials.gov ID: NCT07714512
What this study is testing
What is Isatuximab?
Isatuximab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for aplastic anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I/II clinical study in adult patients with refractory severe aplastic anemia (SAA). Eligible patients must meet the criteria for refractory SAA and have a platelet count (PLT) \<30 × 10\^9/L and/or hemoglobin (HGB) \<90 g/L at enrollment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosed with primary acquired aplastic anemia according to the 2024 British Society for Haematology guideline, Guidelines for the Diagnosis and...
- Previously diagnosed with severe aplastic anemia (SAA) or very severe aplastic anemia (VSAA), with no response or relapse after receiving...
- Hemoglobin \<90 g/L or platelet count \<30×10\^9/L
- Unsuitable for or unwilling to undergo hematopoietic stem cell transplantation, with no better available treatment options.
- Age ≥18 years, regardless of gender.
You likely can't join if
- Diagnosed with congenital bone marrow failure syndromes
- Bone marrow reticulin fibrosis grade ≥2
- people with a paroxysmal nocturnal hemoglobinuria (PNH) clone ≥50% or active hemolysis
- people with clonal cytogenetic abnormalities characteristic of myelodysplastic syndromes, except +8, del(20q), and -Y
- Active bacterial, viral, or fungal infection within 2 weeks before the first dose of the investigational drug, excluding common cold and...
- Active bleeding in the gastrointestinal tract, respiratory tract, central nervous system, or other sites
See the full eligibility criteria
- Diagnosed with primary acquired aplastic anemia according to the 2024 British Society for Haematology guideline, Guidelines for the Diagnosis and Management of Adult Aplastic Anaemia, and the Chinese Guideline for the...
- Previously diagnosed with severe aplastic anemia (SAA) or very severe aplastic anemia (VSAA), with no response or relapse after receiving anti-thymocyte/anti-lymphocyte globulin (ATG/ALG) in combination with...
- Hemoglobin \<90 g/L or platelet count \<30×10\^9/L
- Unsuitable for or unwilling to undergo hematopoietic stem cell transplantation, with no better available treatment options.
- Age ≥18 years, regardless of gender.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
- Willing and able to comply with the requirements for this study and written informed consent.
- Diagnosed with congenital bone marrow failure syndromes
- Bone marrow reticulin fibrosis grade ≥2
- people with a paroxysmal nocturnal hemoglobinuria (PNH) clone ≥50% or active hemolysis
- people with clonal cytogenetic abnormalities characteristic of myelodysplastic syndromes, except +8, del(20q), and -Y
- Active bacterial, viral, or fungal infection within 2 weeks before the first dose of the investigational drug, excluding common cold and onychomycosis, or any other serious infection. Any anti-infective treatment course...
- Active bleeding in the gastrointestinal tract, respiratory tract, central nervous system, or other sites
- A history of any clinically significant disease that, in the investigator's opinion, would pose a safety risk to the subject if participating in the study, or would affect the evaluation of how well it works or safety...
- Use of agents targeting B cells or plasma cells within 3 months before the first dose of the investigational drug or anticipated use during the clinical trial
- Treatment with anti-lymphocyte globulin or anti-thymocyte globulin within 6 months before the first dose of the investigational drug
- Treatment with tacrolimus, sirolimus, cyclophosphamide, anti-CD52 monoclonal antibody, or similar therapies within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of the investigational drug
- Planned participation in another clinical trial, or prior exposure to another investigational product before the first dose, with an interval of less than 4 weeks or 5 half-lives of the drug, whichever is shorter
- Receipt of a live attenuated vaccine within 4 weeks before the first dose of the investigational drug or planned receipt during the study, or receipt of a COVID-19 vaccine within 7 days before dosing
- Prior treatment targeting CD38
- Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study
- Patients considered to be ineligible for the study by the investigator for reasons other than the above
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.